FDA Adverse Event
Malfunction
Summary report: N
COMPRESSOR MINI
MDR report key: 3902084
·
Received February 24, 2014
Report
- Report Number
- 8010042-2014-00054
- Event Type
- Malfunction
- Date Received
- February 24, 2014
- Date of Event
- February 6, 2014
- Report Date
- February 6, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- BTI
- PMA / PMN Number
- K023354
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SERVICE TECHNICIAN HAS BEEN ON SITE FOR TROUBLESHOOTING. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN THE COMPLETE INVESTIGATION HAS BEEN FINALIZED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE COMPRESSOR HAS A BURNT PLUG. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114382 | COMPRESSOR MINI | BTI | BTI | MAQUET CRITICAL CARE AB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |